FDA looks to regulate electronic cigarettes

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E-cigarettes are battery-powered devices that heat up nicotine-laced liquid, turning it into a vapor the user inhales.

By Brady Dennis
Washington Post
April 24, 2014

WASHINGTON — The Food and Drug Administration will for the first time regulate the booming market of electronic cigarettes, as well as cigars, pipe tobacco, and hookahs, under a proposal to be released Thursday.

The move would begin to place restrictions on the nearly $2 billion a year e-cigarette industry, which for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to put restrictions on sales to minors, stop handing out free samples, place health warning labels on their products, and disclose the ingredients. E-cigarette makers also would be banned from making health-related claims without scientific evidence.

The FDA’s proposal stops short of broader restrictions sought by manytobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda, and pina colada — all tactics that critics say are aimed at attracting young smokers and which have been banned for traditional cigarettes.

Those restrictions may come eventually, FDA officials said, but not before more rigorous research can establish a scientific basis for tougher rules.

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‘‘Right now, for something like e-cigarettes, there are far more questions than answers,’’ said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

Thursday’s action is about expanding the FDA’s authority to products that have been ‘‘rapidly evolving with no regulation whatsoever,’’ in order to create a foundation for broader regulation in the future, he said. ‘‘It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.’’

Zeller and FDA Commissioner Margaret Hamburg discussed outlines of the proposal with reporters Wednesday under an agreement that no details would be published until Thursday morning.

E-cigarettes vary from brand to brand, but they generally resemble the size and shape of traditional cigarettes. Instead of burning tobacco, the battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales. Supporters argue that makes e-cigarettes an attractive alternative to their cancer-causing tobacco counterparts.

Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads, and explicit approval of new products. The law also gave the FDA authority to broaden its jurisdiction over other tobacco-related products. While the agency has long indicated that it planned to do just that, action as been slow in coming.

‘‘In the absence of any meaningful regulation, the e-cigarette manufacturers have acted as if it’s the wild, wild West, with no rules and no restraints,’’ said Matthew Myers, president of the Campaign for Tobacco-Free Kids, who had not seen the details of the FDA proposal.

Whatever changes are coming will not happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime.

The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison to the estimated $80 billion-a-year US market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds, and Altria have entered the e-cigarette market in recent years, joining hundreds of smaller manufacturers.

The move toward federal regulation also comes amid an impassioned debate over simple questions that so far have no simple answer: Will e-cigarettes eventually cause more people or fewer to smoke? Will the devices emerge as a healthier alternative that make cigarettes obsolete, or will they act as a gateway to smoking and undermine a half-century of efforts to reduce tobacco-related deaths, which still kill an estimated 480,000 Americans annually?

‘‘There’s such a huge debate over whether e-cigarettes are a good thing or a bad thing for public health,’’ said Kenneth Warner, a tobacco researcher and professor of public health at the University of Michigan. ‘‘But we’re in a kind of factual vacuum. There are not that many [reliable] studies. . . . We really don’t know the right answer.’’

Warner, who had not seen the proposal, said the FDA will have to walk a fine line in the way it treats e-cigarettes. On one hand, the agency must set reasonable restrictions, such as keeping nicotine-delivery devices out of the hands of minors and creating safe manufacturing standards. On the other hand, if e-cigarettes do hold the potential to help some people quit smoking, the agency doesn’t want to stymie innovation and crush an industry that’s quickly evolving.

The cigar and e-cigarette industries have long been preparing for the inevitability of federal regulation — and working hard to try to shape it. For example, makers of ‘‘premium cigars’’ have been lobbying to not be lumped in with the fruit-flavored, corner-store varieties that public health experts say target kids — a distinction FDA officials have said they are willing to consider.

E-cigarette executives have been every bit as aggressive, making their case over the past year in meetings with FDA regulators, members of Congress, and state and local officials, seeking to avoid some of the stringent rules that govern conventional cigarettes. In essence, they have argued that e-cigarettes vapor is far less harmful than cigarette smoke, with its cancer-causing toxins, and can actually help smokers kick the habit. Therefore, the manufacturers say, they should be subject to kinder, gentler oversight — and lower taxes — than traditional cigarettes.

At the same time, manufacturers have been fighting growing regulation.

About 40 cities and towns in Massachusetts, including Boston, have banned e-cigarettes in public places, as have Los Angeles, Chicago, and other cities, according to Americans for NonSmokers’ Rights. Massachusetts Attorney General Martha Coakley is among dozens of state attorneys general who have urged federal regulators to speed up restrictions on marketing the devices to the young.